Animal healthcare well-being and nutrition

ABSTRACT

This invention relates to a method, system and apparatus for the management of comprehensive and cumulative genetic and health assessment databases in relation to animals worldwide. More specifically, the invention is directed to methods and systems that are used to determine animal health care, well-being and nutrition.

This application relates to application Ser. No. 09/419,192, which wasfiled on Oct. 15, 1999; application Ser. No. 09/432,851, which was filedon Nov. 2, 1999; and application Ser. No. 09/898,193, which was filed onJul. 2, 2001; and Application Ser. No. 60/305,443, which was filed Jul.13, 2001. The contents of these applications are incorporated byreference herein.

BACKGROUND OF THE INVENTION

A. Technical Field

This invention relates to a method, system and apparatus for themanagement of comprehensive and cumulative genetic and health assessmentdatabases in relation to animals worldwide. In particular, the inventionrelates to a bioinformatics system and its implementation in relation toanimal biological data. More specifically, the invention is directed tomethods and systems that are used to determine animal health care,well-being and nutrition.

B. Related Art

Substantial investments in time, effort and financial resources are madeby breeders, owners, and caregivers of animals, particularly purebredanimals, to characterize the animal's health state. Thischaracterization may include determining the animal's genetic backgroundand predicting the animal's morbidity, mortality and longevity. Theprobability that an individual animal will develop a specifichealth-related condition in its lifetime is a product of complexinteractions between its genetic makeup, environmental influencesincluding diet, and agents of disease (i.e., chemical, physical, orbiological) that it encounters. Thus, perhaps the best indicator ofoverall health of an individual animal or breed is longevity.

1. Phenotype Data

Generally, the phenotype is the genetic nature of an organism that isrevealed by visible characteristics or measurable performance. Phenotypedata or information includes physical descriptive and health assessmentprofile characteristics. These characteristics, include, for examplephysiological, pathological, endocrinological, hematological,epidemiological, behavioral, and immunological data from parameters suchas phenotype, breed, lifespan, health history, and presence ofinfectious diseases and metabolic disorders.

Blood and other biological samples of a subject animal are analyzed bylaboratories having a central database processing resource (CDPR). Thisis a system for obtaining the phenotypic information. Communicationsystems are known for connecting these laboratories with veterinaryclinics through a telephone and/or fax connection on an automated basis.These systems permit the veterinarian, animal hospital, or otherauthorized person (collectively or individually termed the “remoteuser”) to receive the health assessment profile and basic descriptiveidentifying data, namely phenotypic information, of a subject animalfrom the CDPR. Until recently, it was not possible for the remote userto access the CDPR directly to obtain this phenotypic information of asubject animal.

Typically, a breeder and/or owner of animals obtains health assessmentsof their animals by submitting blood or other body fluid or tissuesamples to a veterinarian or veterinary clinic. The veterinarian orveterinary clinic submits the sample to a laboratory for analysis of thebiological, physiological, or pathological condition of the animal. Thedata (physical health of the animal) are reported to the owner throughthe veterinarian or veterinary clinic. The data also can be stored onthe CDPR of the laboratory. Additionally, for each subject animal, thephenotypic data can be stored on a computer storage system at theveterinary clinic or in a computer storage system of the owner and/orbreeder. The retrieval of the data can be electronically, by voice, hardcopy, or fax as required.

Seeking, obtaining and storing this phenotypic information is driven bythe needs of the animal breeder, owner or the agent of the owner and theanimal's healthcare provider. This information is sought to resolve theclinical, diagnostic, management, and therapeutic needs of an animalsubject when the animal is in need of periodic wellness examination, isill, or is to be restored to a well condition.

2. Genotype Data

A second aspect of data associated with animals is genetic or genotypedata or information. The genetic constitution of an organism includesgenes without visible effects as well as those revealed by thephenotype. Genetic data are typically used to estimate the presence andprevalence of disease and/or disorder among different breeds or kinds ofanimals. Genotypic information is most often stored manually in anon-CDPR facility, for example, select clinical research databases, bookform, hard copy, or genetic disease registries.

Some of the genetic registries are related to specific diseases ordisorders, for instance, hip dysplasia, eye conditions, thyroidconditions, and blood conditions. When retained in a genetic diseaseregistry, the data typically list only those animals that are notaffected with or carrying the heritable trait in question. These geneticregistries are normally the subject of confidential knowledge of abreeder and/or owner, and not the subject of a generally accessibledatabase. These are retained as confidential by the owners either forfinancial reasons, risk reasons, legal liability reasons, or personalreasons.

Thus, genotypic information is transmitted manually to and from personsor local and national genotypic databases maintained for specificdisorders, and designed to foster research into diseases and disorders,rather than being readily accessible to users for clinical purposes inthe manner of phenotypic data on a CDPR

3. Failings of the Existing Systems

There is a need to develop these data in a cumulative, comprehensive,and dynamic system of database management to thereby enhance the healthpredictability, and longevity of animals. This type of comprehensive andcumulative database on individual or groups of animals needs to bepreserved and shared locally, regionally, nationally, and globally. Amechanism to do this is presently not known due to the variousconstraints surrounding each of the two types of databases. Thephenotype database storage, use, and access is fashioned, formed andstructured for use by clinical laboratories and veterinarians. Thegenotype information is fashioned and structured generally for clinicalresearch and breeder/owner uses as opposed to clinical medical uses.

There is also a need for a new database management bioinformatics schemeand relational database, together with computerized networks thatmanage, analyze, and/or integrate comprehensive and cumulative animalhealth assessment data and genetic identifier, genomic mapping, andgenetic assessment data. Current laboratory and research systems andcomputerization have not achieved this, and nor have communicationprotocols been used effectively in this technological area to facilitatesuch a relationship or relational bioinformatics database system formanagement and dissemination of this comprehensive and cumulativeinformation.

More specifically, it is necessary in animal health diagnosis and carethat appropriate predictive testing for diseases and disorders ofanimals be achieved in order to reduce morbidity and mortality, andimprove the quality of life and lifespan. Currently, available testingis unnecessarily complex and expensive in relation to the ability to bean accurate predictor of diseases and disorders in animals.

The present invention is the first to store and/or present phenotypicinformation and genotypic information as a comprehensive and cumulativeassessment of individual animal subjects, families of subjects, breedsof subjects, or species of animals in a computerized format which isavailable through computer networking to authorized remote users.

BRIEF SUMMARY OF THE INVENTION

One embodiment of the present invention is a dynamic method and systemof managing the health care and well-being of a non-livestock animalsubject. Such an animal is preferably a canine subject or a felinesubject. This method comprises obtaining a database relating to at leastone of the species of the animal or selected group of the species. Next,the method comprises obtaining data relating to the animal, for examplelaboratory test data relating to the animal. The next step involvesrelating the database with the data using a computer; and determining aregimen for the management of the animal.

A further embodiment of the present invention is a method of managingthe nutrition of a non-livestock animal. This method comprises obtaininga database relating to at least one of the species of the animal orselected group of the species. Next, the method comprises obtaining datarelating to the animal, for example laboratory test data relating to theanimal. The next step involves relating the database with the data usinga computer; and determining a nutritional regimen for the management ofthe animal. The nutritional regimen is at least related to the nutrientor caloric composition, or the food allergies and food intolerances. Thetherapeutic intervention or maintenance may include drugs,nutraceuticals, vitamins, antioxidants, holistic treatments, exercise orliquid intake.

Another embodiment of the present invention is a method of managing thehealth of a non-livestock animal. This method comprises obtaining adatabase relating to at least one of the species of the animal orselected group of the species. Next, the method comprises obtaining datarelating to the animal, for example laboratory test data relating to thesubject. The next step involves relating the database with the datausing a computer; and determining a therapeutic intervention ormaintenance for the management of the animal.

The database of at least one of the species or the group is periodicallyupdated thereby to obtain cumulative data of the species or group.Preferably both these data bases are used, and preferably both areupdated to obtain the cumulative data. The data of the animal isperiodically updated thereby to obtain cumulative data. Preferably, boththe databases are periodically updated. The updating picks up data driftin different populations of the animals, groups and species over time,and thereby allows for the regulation of the database so as to besubstantially or essentially current.

The invention also includes the step of reporting the determination ofthe health care, well-being, nutrition or other therapeutic requirementsand suggestions or health on a communications network including theInternet. Preferably, there is a payment procedure for the report whichis achieved through the Internet. This communication network andstructure is described here in further detail.

Yet further, another embodiment of the present invention is a method ofmodulating disease of a non-livestock animal. This method comprisesobtaining a database relating to at least one of the species of theanimal or selected group of the species. Next, the method comprisesobtaining genotypic data relating to the animal, for example genotypicdata relating to the animal. The next step involves relating thedatabase with the data using a computer; and determining a nutritionalregimen to modulate the disease.

Another embodiment of the present invention is a method of modulating adisease in a non-livestock animal comprising performing a DNA test todetermine a known DNA marker associated with the disease and determininga nutritional regimen to modulate the disease based on the data obtainedfrom the DNA test.

The foregoing has outlined rather broadly the features and technicaladvantages of the present invention in order that the following detaileddescription of the invention may be better understood. Additionalfeatures and advantages of the invention will be described hereinafterwhich form the subject of the claims of the invention. It should beappreciated by those skilled in the art that the conception and specificembodiment disclosed may be readily utilized as a basis for modifying ordesigning other structures for carrying out the same purposes of thepresent invention. It should also be realized by those skilled in theart that such equivalent constructions do not depart from the spirit andscope of the invention as set forth in the appended claims. The novelfeatures which are believed to be characteristic of the invention, bothas to its organization and method of operation, together with furtherobjects and advantages will be better understood from the followingdescription when considered in connection with the accompanying figures.It is to be expressly understood, however, that each of the figures isprovided for the purpose of illustration and description only, and isnot intended as a definition of the limits of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention, reference isnow made to the following descriptions taken in conjunction with theaccompanying drawing, in which:

FIG. 1 is an overall view of a web-based system to provide access to adatabase management system of an animal genetic database and a healthassessment database of the invention, in relation to the Internet.

FIG. 2 is a graphical illustration of a computer network, namely theInternet.

FIG. 3 is a block diagram of an exemplary computer system for practicingvarious aspects of the invention.

FIG. 4 is a view of a browser for the database management system foraccessing an animal genetic database and a health assessment database ofthe invention.

FIG. 5 is a basic flow diagram illustrating an exemplary process bywhich an operator of a CDPR receives and transmits data relating tohealth assessment and genetic information.

FIG. 6 is a detailed flow diagram of the system steps employed in oneembodiment of the present invention wherein a remote user accesses andoutputs data.

FIG. 7 is a detailed flow diagram of the methods and steps employed by aremote user to add data to the database.

FIG. 8 is a flow chart illustrating an exemplary process by which thelaboratory dynamically contributes, transmits and receives dataassociated with health assessment and genetic data to the CDPR

DETAILED DESCRIPTION OF THE INVENTION

The present invention is now described in detail with reference to a fewpreferred embodiments thereof, as illustrated in the accompanyingdrawings. In the following description, numerous specific details areset forth in order to provide a thorough understanding of the presentinvention. It is apparent, however, to one skilled in the art, that thepresent invention may be practiced without some or all of these specificdetails. In other instances, well known process steps have not beendescribed in detail in order to not unnecessarily obscure the presentinvention.

As used herein, the use of the word “a” or “an” when used in conjunctionwith the term “comprising” in the sentences and/or the specification maymean “one,” but it is also consistent with the meaning of “one or more,”“at least one,” and “one or more than one.”

As used herein, the term “companion animal” includes, but not limited todogs, cats, horses, farm animals, food animals, live-stock animals, zooanimals or wild animals. Preferably, specific families of companionanimals include, but are not limited to canine, feline, equine, bovine,porcine, avian, caprine, and ovine. More preferably, companion animalsinclude canine species, feline species, avian species and equinespecies.

The term “disease” as used herein is defined as a disorder or conditionthat disrupts body functions, systems or organs.

As used herein, the term “genotypic information” refers to informationrelating to the genetic constitution of an animal. This information mayinclude data obtained from the pedigree, family history, heritablephysical characteristics, genetic screening tests, DNA testing, genomicmapping, and related laboratory assessment of the gene product for knownor suspected congenital and heritable traits of a particular animal,animal family, line, or group of animals.

As used herein, the term “gene product” refers to the specificphenotypic characteristic(s) resulting from the expression of thegenotype, and may include certain specific laboratory test data.

As used herein, the term “group” has many different characteristics. Itcan include, for example, a specific breed of animal, a specific purposefor which these animals are used, such as those who are purely companionpets in a home situation, performance animals for show conformation, forobedience, working trials, coursing trials, and for sheep herding andother herding purposes. It can also involve groups of animals dependingon where they live—in a temperate climate, a warm or tropical climate,an arid desert climate, or a cold northern climate. It can include, ofcourse, animals that live in urban and rural areas, animals that livenear water, animals of various ages, intact or neutered, and forreproduction. In other words, the term “group” is used in a very broadsense and can apply to any group that the user wishes to inquire of thedatabase. Thus, the term group is any selected subset of the healthy ordiseased or disordered animals within the entire database.

As used herein, the term “health assessment profile of an animal”typically relates to a particular subject of the group, as opposed tothe group of animals as a whole.

As used herein, the term “heterozygotes” refers to having differentallelic genes at one or more paired loci in homologous chromosomes. Oneof skill in the art is aware that a heterozygote animal is an animalthat contains one allele for a specific disease or is missing an alleleresulting in a specific disease. Thus, a heterozygote animal istypically referred to as a carrier for the disease.

As used herein, the term “nutraceutical” compositions are preparationsof natural ingredients that are multi-component systems consisting ofpreferably synergistic natural products and supplements to promote goodhealth. Nutraceutical compounds can be derived from medicinal plants.

As used herein, the term “nutritional supplements” refers tonutraceuticals, anti-oxidants, vitamins, minerals, or nutraceuticals.

As used herein, the term “nutritional regimen” may include, but is notlimited to pre-selected, pre-prepared food, foostuffs, treats, drinks,nutritional supplements, holistic treatments or exercise.

As used herein, the term “phenotypic information” refers to physicalattributes, breed and other descriptive and health assessmentinformation. Thus, one of skill in the art is aware that a phenotype isassigned on the basis of one or more characteristics that are observableclinically or by laboratory means that reflect genetic variation orgene-environment interaction.

The term “prophylactic” as used herein is defined as a drug or agentwhich acts to prevent a disease or condition.

The term “treatment” as used herein is defined as the use of a drug as atherapeutic or prophylactic therapy. A skilled artisan is cognizant that“treatment” refers to the management and care of an animal for thepurpose of combating a disease, disorder or condition. Thus, the termtreatment as used herein is all inclusive of the acts of curing adisease, preventing a disease or merely managing a disease.

The term “therapeutic” as used herein is defined as a drug or agent,which acts to treat a disease or condition.

A. Genetic Screening and Counseling of Purebred Animals

The common practice to line-breed and inbreed purebred animalsfacilitates the transmission and recognition of congenital and heritabledefects. Large-scale screening programs for the identification ofgenetically affected and carrier animals are an effective way todiscover and eventually control the frequency of these defects withinthe population at large. Screening programs of this type have been usedsuccessfully in humans for many years (i.e., Tay-Sachs disease,phenylketonuria) and more recently have been applied to animals (i.e.,mannosidosis in cattle; hip dysplasia, eye, blood and heart diseases indogs). Genetic screening may be essential to the survival of breeds inwhich mild or moderately severe defects have been propagated unknowinglyfor many generations.

Most purebred animals raised today have evolved over the years from arelatively small gene pool. Even though a particular genetic disordermay initially have been recognized in a specific line or family within abreed, all important breeding stock of the breed need to be screenedbecause their genotype evolved from the original restricted gene pool.If this approach is not taken, the frequency of genetic defects in thebreed will inevitably increase and have a negative impact on overallhealth and longevity.

Depending on the mode of inheritance, different approaches may need tobe applied for the detection and control of genetic disorders. It isadvantageous to be able to select against heterozygotes (carriers)rather than have to eliminate affected individuals from a breedingprogram once the condition is manifested. Control and elimination of thedisease by testing are feasible and reliable in cases where theasymptomatic or carrier state has an expressed phenotypic and/orbiochemical marker (i.e., as measured in a blood, urine or saliva test,electrocardiogram, skin biopsy, eye examination, or hair analysis). Somecurrent examples include testing for bleeding disorders like vonWillebrand disease and hemophilia; autoimmune thyroid disease leading tohypothyroidism; various eye, heart, metabolic enzyme and storagedisorders; and bone and neuromuscular diseases.

B. Features Related to Genetic and Other Data Associated with Animals

1. Physical Characteristics of Disease

In the early days when animal breeders began recognizing recurringsymptoms of disease states or physical characteristics, the undesirablefeatures of these traits led them to select away from the problems bytest mating and eliminating affected animals from the breeding pool.While this remains one way to select against inherited and congenitaldiseases, more reliable approaches have been implemented by screeningfor biochemical markers and most recently by using molecular genetictechniques.

A comprehensive worldwide database contains the following informationfor individual purebred animals:

-   -   Host characteristics: age, sex, neuter status, pedigree, height,        weight, body mass index, coloration and markings, eye color,        etc.    -   Diet: type and amount of dog and human foods consumed, vitamin        and mineral supplements, frequency of feeding. This is used to        derive the percentage of calories derived from fat,        carbohydrate, and protein.    -   Medical history: occurrence of diseases, infections, etc.,        including date of onset, treatment, duration, and outcome, cause        of death and method of diagnosis; type and amount of medications        used for treatment or prevention of disease; type and frequency        of vaccinations.    -   Personality and temperament: based on previously used        personality scales.    -   Laboratory data: consists of routinely collected blood, serum        chemistry tests, urinalysis, etc., as well as laboratory tests        performed to screen for or diagnose specific conditions such as        immune-mediated thyroiditis, hypothyroidism, cancer, etc.    -   Special diagnostic test results: include tests for hip        dysplasia, congenital eye diseases, congenital heart diseases,        blood disorders, and other suspected inherited disorders as        tests become available.    -   Genetic information: derived from the canine genome project as        well as tests for specific inherited conditions such as        progressive retinal atrophy, hemophilia, and von Willebrand        disease.

Although this comprehensive worldwide database is available forindividual purebred animals, there still exists a need to develop adatabase for none purebred animals. Thus, the present inventioncontemplates the development of such a database containing phenotypicand genotypic information relating to purebred and non-purebred animals.It is envisioned that this database can be used to predict and/ordiagnosis disease in an owner's and/or breeder's animal. Yet further,the present database can be used to manage diseases and/or preventdiseases by predicting the disease and determining a nutritional regimenfor management and/or prevention of a disease in the animal.

2. Phenotypic Markers of Disease

For about three decades, veterinary and comparative geneticists havedeveloped and relied upon physical and biochemical markers of specificgenetic traits to identify carrier (heterozygotes) and affected animals.These methods aimed to produce reliable, practical, and affordable teststhat may be predictive of the gene product, and therefore the genotypeof a particular genetic disorder. To be considered accurate andpredictive, retrospective analyses of data developed from these testingprograms were compared to the pedigrees of animals being screened as ameans of validating the tests. Such genetic screening tests may beconsidered reliable if they correctly identified animals as having thenormal and abnormal genotypes at least 80% of the time.

An important indicator of overall health of an individual animal orbreed is longevity. Relationships between a specific health-relatedcondition and an animal's genetic, environmental influences and lifespanhave been characterized, in part, for several important diseases of dogsincluding bone cancer (osteosarcoma) and gastric dilatation-volvulus(GDV). For example, the risk of osteosarcoma increases with increasingage, increasing weight and increasing height. Compared with the Germanshepherd breed, the highest risk of osteosarcoma occurs among large andgiant breeds, while small breeds have reduced risk. Furthermore, therisk of osteosarcoma is increased two-fold in neutered dogs. Yetfurther, factors that increase the risk of GDV in purebred dogs are malegender, being underweight, eating only one meal per day, eating rapidly,and a fearful temperament. Factors that decrease the risk of GDV includea happy temperament and inclusion of table foods in the diet. Thelifetime risk of developing GDV in large and giant breed dogs is 20% and23%, respectively, whereas the lifetime risk of dying of GDV for thesebreeds is 6%.

Similarly, the comparative longevity of different dog breeds has beendescribed using the age of death and other descriptive characteristicsof more than 38,000 dogs that were included in a large veterinarydatabase. Predictable relationships were found between the breed andsize of dogs and the average age of death. It was noted that dogs areunique among animal species in having a more than 50-fold difference inadult body size and a corresponding large difference in longevitybetween the smallest and biggest dog breeds. Since these dog breeds havemore than 99% of their genome in common, it suggests that the geneticcode for both size and longevity is contained within a very small partof the dog's genome. As mapping of the canine genome progresses, it ispossible to identify not only genes that code for specific diseases suchas cancer and GDV, but also for the genes that determine body size andlongevity.

3. Genotypic Markers of Disease

Recent advances in molecular genetics have focused on mapping the humangenome, and this has stimulated interest in developing parallel geneticmaps for animals. For example, it is estimated that a minimum of tenyears and several million dollars is needed to map the canine genome.Once developed, a genetic map provides information about the relativeorder and placement of genes or specific DNA markers on specificchromosomes. This allows one to locate specific regions on chromosomeswhere genes of interest are likely to be found. Once a molecular markeris identified close to a specific gene of interest, screening tests forthis particular marker can be used to identify individuals carrying orexpressing the trait.

Thus, the present invention has contemplated the use of a single test,such as a DNA test, to determine the genetic profile of the animal. Oncea DNA marker is determined for a specific disease and/or disorder, astandard DNA test well known and used by those of skill in the art canbe preformed to determine the presence and/or absence of the DNA marker.Such test may include, PCR-based methods, Southern blot, oligonucleotidearrays, etc.

Some of the characteristics of animals with which this invention isconcerned are the following: Genotype & Some Mostly Phenotype AnimalCharacteristics Phenotype Mostly Genotype (Gene Product) Species XPurebred X Crossbred X Mixed breed X Size X Weight X Age X Sex XLifespan X Body type X Color X Family history X DNA testing X Genomicmapping X Blood type X Thyroid function X von Willebrand factor XHemophilia X Other bleeding disorders X Glucose X Cholesterol X Alkalinephosphatase X Alanine aminotransferase X Bile acids X Cortisol XCataracts X Progressive retinal X atrophy Microophthalmia X Dry eye(KCS) X Hip dysplasia X Arthritis X Temperament X Ruptured cruciate Xligament Hemolytic anemia X Urinalysis X Kidney stones X Bloat (gastricdilatation) X Pyoderma X Seborrhea X Sebaceous adenitis X Umbilicalhernia X Inguinal hernia X Epilepsy X Heartworm disease X CardiomyopathyX Patent ductus arteriosus X Immunoglobulin levels X

In the category of genotype and some phenotype, the phenotype component(measurable gene product) is typically less than 20%.

C. Diagnostic Testing

The development of one or more assays or techniques for performing theinvented testing protocols, standards and procedures of the presentinvention is straightforward, and within the knowledge of a personskilled in the art. The contents of U.S. Pat. No. 5,830,7009 (Benson)entitled “Detection Method for Homologous Portions of a Class ofSubstances” is indicative of some of the tests and formats that arepossible. The contents of that patent are incorporated by referenceherein.

One or more of a panel of tests relate to at least one of endocrinefunction, immunologic function, gastrointestinal function andnutritional analysis, inborn errors of metabolism, paternity, DNAfingerprinting, hemostasis and coagulation function, vaccinal antibodystatus, adverse and potential adverse vaccine reaction, infectiousdiseases, pathology, blood typing and bone marrow analysis, cellcytotoxicity, cytokines and allergy testing, and markers of neoplasticor paraneoplastic change. These data are relevant to the likelymorbidity, likely longevity, and/or the potential risk for disease ordisorder for the animal. One of skill in the art is aware that as usedherein the term “DNA fingerprinting” refers to genetic profiling, forexample, but not limited to profiling for disease susceptibility.

The following are some specific diagnostic test panels and specializeddiagnostic tests and test groups used to monitor health, morbidity,mortality and longevity of animals and animal families, and to predictthe potential risks of disease or disorder.

1. Test 1: Comprehensive Diagnostic Test Panel

Patient phenotypic descriptors and genotypic descriptors/background;complete blood count (CBC) and platelet count, platelet size, plateletmorphology; serum chemistry profile [i.e., AST (SGOT), ALT (SGOT),bilirubin (total, direct and indirect), alkaline phosphatase, GGT(GGTP), total protein, albumin, globulin, A/G ratio, cholesterol, BUN,creatinine, BUN/creatinine ratio, phosphorus, calcium, correctedcalcium, calcium/phosphorus ratio, glucose, amylase, lipase, sodium,potassium, Na/K ratio, chloride, CPK, triglyceride, osmolality];complete thyroid profile (total T4, total T3, free T4 (ED or other),free T3, T3 autoantibody, T4 autoantibody, TSH, thyroglobulinautoantibody); and urinalysis, urine culture, and sensitivity, ifindicated.

2. Test 2: Diagnostic Test Panels for Endocrine Function

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all of selected tests from the following list:

-   -   1) Thyroid Function: total T4, total T3, free T4 (ED or other),        free T3, T3 autoantibody, T4 autoantibody. Molecular screening        for autoimmune thyroiditis including immunoglobulin receptors on        B-cells, T-cell receptors, and major histocompatibilty complex        (MHC) genes Class I and II allellic HLA, DLA, or equivalent        animal antigenic specificities (RFLP, PCR/SSO, PCR/SSP).    -   2) Adrenal Function: cortisol (basal and after stimulation with        ACTH, or serially after suppression with high or low-dose        dexamethazone); endogenous cortisol; and endogenous ACTH.    -   3) Reproductive Function: testosterone; estradiol-17β; relaxin        (pregnancy diagnosis); progesterone; luteinizing hormone;        estrone sulfate; follicle stimulating hormone; vaginal cytology        and/or culture; testicular cytology or biopsy; prostatic        cytology, biopsy or wash; screens for ovarian or testicular        remnants.    -   4) Pancreatic Function: amylase; lipase; glucose; glucagon,        trypsin-like immunoreactivity (TLI); insulin, fructosamine;        glycosylated hemoglobin.    -   5) Parathyroid Hormone Function: parathormone; ionized calcium.    -   6) Other Endocrine Function: aldosterone; 21 adrenal        hydroxylase; vanylla mandelic acid (VMA, for epinephrine and        norepinephrine metabolities).

3. Test 3: Diagnostic Test Panels for Immunologic Function

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all of selected tests from the following list:

Antinuclear antibody (ANA)—if positive, run double stranded, singlestranded, speckled, anti-RNA levels; Coombs' testing (direct andindirect; elution or microbeads gel-test); rheumatoid factor; serumelectrophoresis—if abnormal, run immunoelectrophoresis, isoelectricfocusing, immunoblotting (Western, Northern, Southern blots);immunoglobulin levels (IgG, IgA, IgM, IgD and IgE); complement levels(C1, C1a, C1 esterase inhibitor, C3, C4, C5-C9); LE-prep testing; lupusanticoagulant (dilute Russell's viper venom test or dilutional inhibitortest); urine protein SDS-gel electrophoresis; fibronectin andanti-fibronectin antibody; flow cytometry with fluorescence activatedcell sorter (FACS, for leukocyte subsets and markers such as CD4+ andCD8+; leukocyte chemotaxis (leukocyte migration inhibition test,leukotrienes); cytokines including lymphokines and monokines(macrophage-derived) such as the interleukins (IL) [i.e., IL-6 regulatedby estradiol-17β, IL-8 acts as neutrophil chemotactic factor],interferons, tumor necrosis factor(s), leukotrienes, colony stimulatingfacors, transforming growth factor-beta and chemokines (inflammatorycytokines); anti-platelet antibody tests (serum, bone marrow);anti-megakaryocyte antibody tests (IFA, elution); and anti-leukocyteantibody tests (direct and indirect anti-neutrophil cytoplasmicantibody, antilymphocyte antibody, etc.).

4. Test 4: Diagnostic Test Panels for Gastrointestinal Function andNutritional Analysis

Patient phenotypic descriptors and genotypic descriptors/background,plus nutritional and food supplement past and current use, plus any orall of selected tests from the following list:

Serum nutrients and vitamin analysis; CBC as in Test 1; serum chemistryas in Test 1 plus magnesium and iron; urinalysis, urine culture andsensitivity, if indicated; urine fractional excretion; serum and urineamino acid analyses; serum cobalamin (vitamin B12) and folate analysis;TLI [same as Test 2, 4)]; fecal flotation; Giardia screen, Clostridiumperfringens enterotoxin test; cryptosporidiosis test (FA); toxoplasmosistest; bile acids test (resting and post-prandial); fecal alpha-1protease inhibitor activity. If any abnormalities are present, furtherinvestigation includes ion-coupled plasma emission spectroscopy (ICP)for mineral analysis, and electrophoresis.

5. Test 5: Diagnostic Test Panels for Inborn Errors of Metabolism

Characteristics related to presence of or susceptibility to mammarycancer of the animal are determined. Biological laboratory test datafrom a bodily fluid or tissue of an animal are analyzed. The test datarelate to estrogen (estradiol-17β), estrogen receptors, interleukin (IL)6, progesterone, and progesterone receptors. The value should fallwithin predetermined levels as a determinant of presence orsusceptibility to mammary cancer.

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

Genetic screening tests including blood and urine analyses formucopolysaccharides, cerebrosides, glycogen-storage diseases,phenylketones, phosphofructokinase, mannosidases, combined and specificimmunoglobulin deficiencies/dysfunctions; skin and tissue biopsies;karyotyping for genotype determination; and DNA marker analyses.

6. Test 6: Diagnostic Test Panels for Paternity Testing and DNAFingerprinting

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

Major histocompatibilty complex (MHC) Class I and II alleles [analysesof HLA, DLA, or equivalent animal antigenic specificities]; genotyping;gene mapping and fingerprinting.

7. Test 7: Diagnostic Test Panels for Hemostatic and CoagulationFunction

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

Platelet count, platelet size (blood slide, mean platelet volume),platelet morphology (light, scanning, and electron microscopy);prothrombin time; partial thromboplastin time; fibrinogen;fibrin-fibrinogen degradation products (D-dimer test); platelet functiontests (aggregation, release, clot retraction, whole blood aggregation,ristocetin cofactor); von Willebrand factor antigen and multimeranalysis; specific coagulation factor analyses (factors II, V, VII,VIII:C, IX, X, XI, XII, XIII); fibrinolytic tests (plasminogen, plasmin,antiplasmin, tissue plasminogen activator, dilute whole blood lysistest, euglobulin lysis test); anti-thrombin III test; circulatinganticoagulant tests; platelet factors 3 and 4 (heparin cofactor);protein C; protein S; kinin-kinogen tests; prekallikrein test;alpha1-antitrypsin assay; alpha2-macroglobulin assay; C1 esteraseinactivator assay; anti-platelet antibody, and anti-megakaryocyteantibody tests (see Test 3).

8. Test 8: Diagnostic Test Panels for Vaccinal Antibody Status, andAdverse Vaccine or Potential Adverse Vaccine Reaction

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

-   -   1) Serology for Vaccinal Antibody: canine distemper, canine        parvovirus, canine coronavirus, canine parainfluenza virus,        infectious canine hepatitis virus, canine bordetella, canine        Lyme (borrelia), canine leptospirosis, rabies virus, feline        panleukopenia virus, feline leukemia virus, feline infectious        peritonitis virus, feline immunodeficiency virus, feline        calicivirus, feline herpes virus, and equine herpes viruses        (I-IV), etc.    -   2) Adverse Vaccine Reaction: Same as Test 3, but especially CBC;        ANA; Coombs' test; platelet count, size, and morphology;        anti-neutrophil cytoplasmic antibody, marker for vasculitis;        complement tests; leukocyte chemotaxis tests; urine        protein/creatinine ratio; anti-platelet antibody; immunoglobulin        levels, especially IgG, IgA, IgM; flow cytometry (FACS)        leukocyte subsets; cell cytotoxicity analysis; cytokines,        especially chemokines; and complete thyroid autoantibody panel.    -   3) Potential (High Risk) Vaccine Reaction: especially for breeds        such as the Akita, Weimaraner, Standard poodle, Eskimo Dog,        harlequin Great Dane; CBC; ANA; platelet count, size and        morphology; complete thyroid autoantibody panel; cell        cytotoxicity analysis; cytokines; and immunoglobulin levels,        especially IgG, IgA, IgM.

9. Test 9: Diagnostic Test Panels for Infectious Diseases

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

-   -   1) North America: Ehrlichia species (E. canis, E. risticii, E.        equi, E. platys, etc.); Rickettsia rickettsei (RMSF); Borrelia        species (Lyme disease); Bartonella species (B. henselae, B.        vinsonii, B. clarridgeiae, B. kochlerae); systemic fungal        diseases (Coccidioides spp, Cryptococcus spp, Histoplasma spp,        Blastomyces spp, Aspergillus spp, ringworm); mange mites        (Demodex, Sarcoptes, Chyletiella, etc.); enteric diseases        (Clostridium perfringens enterotoxin); protozoan diseases        (Toxoplasma spp.; Coccidia spp; Giardia spp); retrovirses        (feline leukemia virus, feline immunodeficiency virus, equine        infectious anemia virus, bovine leukemia virus, caprine        arthritis virus; Corona viruses (canine coronavirus, feline        enteric coronavirus, feline infectious peritonitis virus;        Babesia spp (B. canis, B. gibsoni); Dirofilaria spp (heartworm);        other parasitic diseases (fleas, ticks, roundworms, tapeworms,        hookworms, Strongyles and other intestinal parasites); and        Chlamydia antigen (PCR testing).    -   2) International: Same as above plus Leishmania spp; Trypanosoma        spp.; Anaplasma spp; Yersina pestis.

10. Test 10: Other Diagnostic Tests

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

Pathology (anatomic, histological, cytologic, immunohistochemical,electromicroscopy, FACS); blood typing; bone marrow analysis andspecific immunohistochemical staining; RFLP and PCR testing (applicableto many of the above categories); IFA and FA testing; ELISA testing,cell cytotoxicity testing, cytokine testing (see Test 3, other cytotoxiccell and mitochondrial tests); markers of neoplastic and paraneoplasticchange (cancer); neurotransmitters including serotonin,gamma-aminobutyric acid (GABA), glutamate, dopamine, glycine, aspartate,acetylcholine, norepinephrine, histamine, substance P, vasopressin,vasoactive intestinal peptide, neurotensin, or other neuropeptides; andamino acid profiling.

D. Comprehensive and Cumulative Database for Animal Health

Comprehensive and cumulative data profiling is utilized over time toallow one to predict the specific nutritional management interventionsthat can assist in the care and management of the very earliest stagesof specific abnormalities or trends that have been identified in thehealth profile of animals, thereby extending and improving their healthand longevity. This is an unique approach to scientifically andmedically determine by comprehensive and cumulative laboratory and/orgenetic profiling of individual animals and animals within specifieddefined groups to permit intervention in prevention, management andtreatment of general and veterinary medical health care.

Specifically, the present invention directs the outcome of thelaboratory and/or genetic profiling to nutritional and nutritionalsupplement management of the specific identified abnormalities andtrends over time. This is not only important but also practical becausenutritional intervention and management is relatively inexpensive,non-invasive and easily accepted by the pet owner and the veterinaryprofessional making these recommendations. Thus, the present inventioninvolves a dynamic method and system of managing the health care,well-being and nutritional requirements of companion animals.

The nutritional regimen is at least related to the nutrient or caloriccomposition needed for the subject, or the food allergies and foodintolerances of the subject. Nutritional regimen can also be therapeuticand/or preventative intervention of the disease and/or disorder. Thenutritional regimen may include pre-selected, pre-prepared food, treats,drinks and or nutritional supplements, i.e., nutraceuticals,anti-oxidants, vitamins or minerals. Yet further, nutritional regimensmay also include holistic treatments or exercise.

For simplicity, an example is described for a dog, however, the presentinvention can be equally applicable to a cat or any other companionanimal. To begin, a database relating to the dog species generally, anda database relating to a selected group, for instance, the breed, of thedog is used. Data is obtained relating to the particular dog subject,and this data includes diagnostic laboratory test data, and ideallycomprehensive and selected diagnostic laboratory data relating to thedog. The database of the selected dog group and the breed, for example,is related to the data of a particular subject dog by a computer. Forexample, the database of the selected group of the species is at leastone of breed, age, sex, size, weight, performance use, or geographicallocation. There is then determined, based on this relationship, aregimen for the management and health care of the dog subject.

Diagnostic laboratory test data is a comprehensive general healthprofile and at least one selected diagnostic profile for a selectedsubject animal. The laboratory data for the subject is ideally obtainedover time from the same laboratory. This is likely to enhance theuniformity of the data, and render the determinations more accurate andpredictive of health, nutritional requirements, temperament, andlongevity.

The database of at least one of the species or the group is periodicallyupdated thereby to obtain cumulative data of the dog species or groupwithin the dog species. Both of these databases generally are be used,and both are updated to obtain the cumulative data. In some cases, onlyone of the databases is used and/or one of them is periodically updated.

The data of the dog subject is also periodically updated. Overall thereis obtained cumulative data of the dog subject, species or group. Theupdating picks up data drift or data trends within different populationsof the particular dog subject, the groups (for instance, breed) and thespecies (for instance, the dog generally as a species) over time. Thisallows for the review and oversight of the database so as to besubstantially or essentially current.

The data of the dog subject is compared to substantially or essentiallycurrent data. Similarly, by retaining a historical record of the dogsubject's data and relating this to the updated databases, the accuracywith which the management of the health care and wellbeing, and thedevelopment and design of nutritional requirements or therapeutic andmaintenance interventions is significantly enhanced. In this manner, forinstance the food, supplements, nutraceuticals and the like, can bemodified by additions and/or subtractions of components based on thedetermined relationship, since these cumulative and dynamic databasesand data analytes change over time, whereby the determined relationshipis significantly enhanced. Management of the dog subject in one or allof these respects is dealt with a high level of precision andpredictability.

The computer is at least one of an expert system or interrelationshipprogram or network for determining data base and data relationships.This can be a system such as a neural network, or other statisticalsampling systems and networks, and is discussed in more detail in latersections of this application.

The determination of the health care, well-being, nutritional or othertherapeutic requirements and suggestions for promoting and maintaininghealth of the dog is reported on a communications network including theInternet. There is a payment procedure for the report which is achievedthrough the Internet.

The system also permits for the access to the genetic and/or phenotypedata through a password and a system whereby access to the datagenerates a fee. This system also provides for a situation whereinpayments can be made by credit card for requests to perform healthassessment profiles and secure genomic mapping and genetic screeninginformation. Such bioinformatics system can also permit for theautomatic payment for such services and products to the banking systemof the database or laboratory. As such, the database may require thatthe payments be guaranteed, for instance by supplying a credit cardnumber with a request for performance of services and a product, and forthe retrieval of such data.

A user can submit a request to the database in any number of ways. Forexample, the request can be submitted via on-line direct connection,namely through a computer network such as the Internet. An intermediateresearcher such as a veterinarian or scientist other than the ownercould also submit the request on behalf of the owner using the e-mailcapabilities of the central database system. Alternatively, the user cansubmit the data via an interactive voice response unit coupled to thedatabase system of the supplier. In some situations, the databasesupplier can decide whether to supply the health assessment informationand/or genomic mapping and genetic screening information based on thecriteria of the user or its intermediary agent. Such user orintermediary agent can be notified of the decision via the interactiveresponse unit or a live operator.

The user or agent can log into the database system and obtain thenecessary records relating to an animal physical health and/or geneticancestry or offspring. The database system can transmit in real time oron a periodic basis as determined, thereby, providing informationregarding the health assessment or the genetic background and forwardthis information to the user and/or its intermediary agent.

The data storage devices of the invention include a variety of databasesincluding a database relating to the phenotypic data of a particularspecies, a database relating to health assessment or other phenotypicdata of particular animals in a particular species, and geneticcharacteristics of different species and different family trees relatingto different species. The family trees contain information including theorigin, genomic map, and parental lines of a species and records ofhealth and performance of a species. These databases are interrelated inan analytical manner and in accordance with different algorithms ofpermutations and probabilities to facilitate useful output informationbased on the combination of data in the genotypic and the phenotypicdatabases, and the selected databases.

In further embodiments, it is envisioned that the method is not adynamic method. For example, the method may involve a single DNA test inwhich the result will not change with time and/or treatment. One suchsingle test includes, but is not limited to a DNA test, which indicateswhether or not the animal has the genetic predictors of the disease,i.e., the presence and/or absence of any DNA marker associated with thedisease. The data from the DNA test can then be interpreted in view ofthe database to determine the nutritional regimen. Thus, the presentinvention may also involve a sequential method and system of managingthe health care, well-being and nutritional requirements of companionanimals.

It is also contemplated that this sequential method may not require theassistance of a database to interpret the data and/or determine thenutritional regimen. The single test provides a positive or negativeresult, which indicates the presence and/or absence of a disease and/ordisorder. Based upon the data from the single test, one can determinethe nutritional regimen without a database.

E. Overall System

Below is a description of the system that is used in the desired methodsto manage the health care, well being and nutritional requirements ofthe companion animal.

FIG. 1 is an overview of the web-based system to provide access to theinvented database management system. With this system multiple users,for instance, remote users 8, access the web site 4 using the Internet6. Each of the users 8 has a computer terminal with the appropriatesoftware for accessing Internet. The users 8 may be unknown to the webserver computers 10 and 12. Each user 8 is allowed to browse the website and explore how the system functions.

There are several aspects to maintain security of information maintainedin the database server 22 and a banking system 28. A firewall 20prevents any user 8 from accessing any of the components behind thefirewall 20. In this way the users 8 have access to the web servercomputers 10 and 12, but only have access to the database server 22through the firewall 20. The database server 22 maintains, among otherthings, various database fields with respect to each of the healthprofiles of subjects and the genetic information of a subject andgroups. The database 22 maintains the services with a designationassociated to determine what health assessment data and genetic data canbe browsed by the users 8. Each of the web server computers 10 and 12allow users 8 to view subject and group categories and actual servicesand data products which are available from the database.

The web server computers 10 and 12 can be identical and can beduplicated as additional load or growth on the system occurs. The webserver computers 10 and 12 share the responsibility for servicing theusers of the site. This arrangement provides for expandability of thesystem by merely adding additional web server computers as necessary.

Preferably, the system includes an appropriate computer terminal 24 forinterfacing with independent financial institutions which are connectedon-line via the serial connection 26 to the financial institutioncomputers 28. This allows automatic real time confirmation of the accessof health profile and genetic data services and products. Once a userrequires access to a product or service, the user goes through anidentification or registration process and the exchange of financialinformation to allow for credit or debit card payment of the purchase.This is verified, confirmed and authorized by the appropriate banksystem institution 28. Confirmation of the purchase or deposit of data,or a service is made by a mail server 34 which sends an E-mail to theuser 8 confirming the purchase or deposit. The mail server 34 allows formail to be received and sent out. Security of the various databases ismaintained. Alert messages are generated when an unauthorized access isattempted. Verification messages, authorization messages andconfirmation messages are generated as appropriate.

The database server 22 is also designed to interact with an inputcomputer 32 operated by a CDPR. A firewall 30 serves to preventunauthorized access to the database server 22 or to the input computer32. The input computer 32 can input health profile data and genetic datato the database, after appropriate access and/or passwords are enteredinto the system. Similarly, users 8 through their own computers can useappropriate access codes and passwords to access input data to thedatabase server 22. This is tightly controlled for security reasons. Thedata may only be added to an independent sub-database of the data server22, and only after scrutiny by the CDPR operator of the database throughinput computer 32, will this data from users 8 be subsequently added tothe main database server 22.

FIG. 2 is an illustration of the Internet and its use in the system ofthe invention. The Internet 6 is a network of millions of interconnectedcomputers 40 including systems owned by Internet providers 42 andinformation systems 44 such as America Online™. Individual or corporateusers may establish connections to the Internet in several ways. A useron a home PC 46 may purchase an account through the Internet provider42. Using a modem 48, the PC user can dial up the Internet provider toconnect to a high speed modem 50 which, in turn, provides a full serviceconnection to the Internet. A user 52 may also make a somewhat limitedconnection to the Internet through a system 20 that provides an Internetgateway connection 54 and 56 to its customers. The database 22 is alsoconnected into the Internet 6 through an appropriate modem or high speedor direct interface 58. The database 22 is operable and maintained bythe CDPR operator computer 60. Users of the databases of the inventionwould access the Internet in an appropriately selected manner.

FIG. 3 is a block diagram of an exemplary computer system 100 forpracticing various aspects of the invention. The computer system 100includes a display screen or monitor 104, a printer 106, a disk drive108, a hard disk drive 110, a network interface 112, and a keyboard 114.The computer system 100 includes a microprocessor 116, a memory bus 118,random access memory (RAM) 129, read only memory (ROM) 122, a peripheralbus 124, and a keyboard controller 126. The computer system 100 can be apersonal computer, such as an Apple computer, i.e., an Apple Macintosh™,an IBM™ personal computer, or a compatible, a workstation computer, suchas a Sun Microsystems™ or Hewlett-Packard™ workstation, or some othertype of computer.

Microprocessor 116 is a general purpose digital processor which controlsthe operation of computer system 100. Microprocessor 116 can be asingle-chip processor or can be implemented with multiple components.Using instructions retrieve from memory, the microprocessor 116 controlsthe reception and manipulation of input data and the output and displayof data on output devices.

Memory bus 188 is used by the microprocessor 116 to access RAM 120 andROM 122. RAM 129 is used by microprocessor 116 as a general storage areaand as scratch-pad memory, and can also be used to store input data andprocessed data. ROM 122 can be used to store instructions or programcode followed by microprocessor 116 as well as other data.

Peripheral bus 124 is used to access the input, output, and storagedevices used by computer system 10. These devices include the displayscreen 104, printer device 106, disk drive 108, hard disk drive 110, andnetwork interface 112. The keyboard controller 126 is used to receiveinput from the keyboard 114 and send decoded symbols for each pressedkey to microprocessor 116 over bus 128.

The display screen or monitor 104 is an output device that displaysimages of data provided by microprocessor 116 via peripheral bus 124 orprovided by other components in computer system 100. The printer device106 when operating as a printer provides an image on a sheet of paper ora similar surface. Other output devices such as a plotter, typesetter,etc. can be used in place of, or in addition to the printer device 106.

The disk drive 108 and hard disk drive 110 can be used to store varioustypes of data. The disk drive 108 facilitates transporting such data toother computer systems, and hard disk drive 110 permits fast access tolarge amounts of stored data.

Microprocessor 116 together with an operating system operate to executecomputer code and produce and use data. The computer code and data mayreside on RAM 120, ROM 122, or hard disk drive 120. The computer codeand data could also reside on a removable program medium and loaded orinstalled onto computer system 100 when needed. Removable programmediums include, for example, CD-ROM, PC-CARD, floppy disk and magnetictape.

The network interface circuit 112 is used to send and receive data overa network connected to other computer systems. An interface card orsimilar device and appropriate software implemented by microprocessor116 can be used to connect computer system 100 to an existing networkand transfer data according to standard protocols. As such he computersystem is connectable through an interface device with the Internet 6.

Keyboard 114 is used by a user to input commands and other instructionsto computer system 100. Other types of user input devices can also beused in conjunction with the present invention. For example, pointingdevices such as a computer mouse, a track ball, a stylus, or a tabletcan be used to manipulate a pointer on a screen of a general-purposecomputer.

The present invention in relation to the animal database management ofdata can also be embodied as computer readable code on a computerreadable medium. The computer readable medium is any data storage devicethat can store data which can be thereafter read by a computer system.Examples of the computer readable medium include read-only memory,random-access memory, magnetic data storage devices such as diskettes,and optical data storage devices such as CD-ROMs. The computer readablemedium can also be distributed over network coupled computer systems sothat the computer readable code is stored and executed in a distributedfashion.

FIG. 4 illustrates a browser system for use with the database system ofthe invention. A browser goes through a number of preliminary screensand logic steps, and reaches a screen 60 entitled “Next Entry”. Thisscreen provides data details or information generally indicated as 62.Clicking on any of these categories allows the user to review databasedetails 64, data specific details as generally indicated by 66. In thisway, the user can index through a number of screens to get informationregarding the different databases of the system. In addition, clickingon any of the triggers 70, 72, 74 and 76 is possible. These correspondto HOW IT WORKS, SECURITY, EXTENDED DATA and PRE-REGISTRATION. Clickingon trigger 70 provides the user with information on how the processworks, explains the system, and provides details on how the user canparticipate in the database and obtain data or input data. Clicking ontrigger 72 provides details regarding security of the system andautomatic payment. In some cases, products and services are offered withextended data and clicking on trigger 74 which can provide details ofthe extended data and explains that this may only be available oncertain services or products.

Trigger 76 allows a user to pre-register and obtain user ID number. ThisID number is combined with financial information retained in thedatabase in an encrypted form. The pre-registration trigger 76 followswith step 78 which is to gather personal information such as credit cardnumber and expiry date to allow for automatic payment. Step 80 is tovalidate a current existence in the database, if this occurs. With anegative answer, the user is directed into a registration processindicate as 82. A user ID is assigned and a password is entered. Thisinformation is maintained in a portion of the database 22. At 84 theuser is provided a screen identifying the user ID at screen 86. If theuser already exists, the registration process is rejected at 88 and theuser is advised of the information at the display 86. The screen at 86would also represent the information which is available in the database22.

In FIG. 5 there is shown a basic block diagram of the components makingup the CDPR. There is the phenotype database or physical health database200 and a genotype database or genetic information database 201. Theseare contained in part of the overall CDPR database 202. User input 203can be obtained from a remote user such as a veterinarian, owner,breeder, or the operator of the database, an agent or researcher. Theoutput from the database 204 could be to the veterinarian, owner,breeder, operator, agent or researcher.

FIG. 6 shows a relationship for retrieving data from the database 202.The user 8 is represented here as a veterinarian, owner, breeder,operator, or researcher 203 who accesses the CDPR 202 accesses a firstscreen through a computer network 6 which inquires about informationabout the user. An access request message is sent, and an appropriateaccess enabling message is transmitted. The user 203 can obtain partialor full access to the CDPR 202 according to the scale of authority givento the user 203 to access data. There is a computer program system 205to ensure that payment is made as appropriate before access to the CDPR202 is granted. In some situations, the appropriate access code 204 canpermit bypassing the payment requirement 205 as indicated by line 206.Payments 205 through the computer program can be effected by a creditcard entry and automatic transfer to a financial institution on behalfof the operator of the CDPR 202. Such payment for access to the databaseis effected by a system which is well known in the art. The financialinstitution will appropriately credit the operator of the CDPR 202 in afinancial manner as established between the operator and the financialinstitution.

Within the CDPR 201 there is the ability to access the physical healthphenotype database 200, the genotype database 201, and other databases207, 208 and 209, respectively. The phenotypic and genotypic informationtogether with other database information can be presented on a singlescreen or monitor or other viewing means, for instance, hard copyformat. The access therefore can be to multiple databases containedwithin the CDPR 202. After accessing the physical health database 200,the user obtains an analysis report from module 210. The user is thenable to read the analysis as indicated by 211 and output the analysisfrom the read-out 211 as indicated by output 212. The output 212 can bea computer screen read-out, fax or voice information.

The physical health or phenotype database 200 is subject or groupspecific. In other words, the data obtained in that database is specificto a particular animal or animal group (breed, family, species, etc.)which has been the subject of a laboratory or research biologicalexamination such that fluid or tissue samples have been subject toanalysis in one or more laboratory or research environments. Thesebiological reports can include those from specimens of blood, urine,other body fluids, skin, eyes, skeletal and other tissues. The PTdatabase 200 has the ability to store the subject specific informationas required within the CDPR 202.

The genotype specific or genetic disorder or disease data is retained inthe database 201 within the CDPR database 202. This data is eithersubject specific, family specific, breed specific, species specific,disorder specific, or disease specific, and is group or subjectspecific. The user can access the genotype database 201 and obtain aread-out 213 which can then be transmitted along line 214 to an output212 in the same manner that the physical health assessment is obtainedas an output.

In an alternative approach, the reader can request an analysis 215 fromthe genotype database as indicated by line 216. This analysis canreceive data along line 217 from the analysis information of thephysical health assessment. Interpretation of the PT and GT can beobtained as indicated by 218, and this can then be outputted asindicated along line 219. The interpretation of PT and GT 218 can beperformed by an algorithm relating to the coefficients andpredictability of information relating to disorders, disease andlongevity when considering the data from the two databases PT 200 and GT201. This can be done automatically and outputted along line 219, orthere can be an expert interface 220 using skilled personnel tointerpret the data of block 218, and this can, in turn, be outputtedalong line 221 to the output 212.

Database 207 can be a genetic marker database, and the information fromthat database can be directly input into the output through a read-out222 and 223 to the output 212. Alternatively, the data from database 207can be added to the interpretation section 218 of the physical healthand genetic information by directing the data along line 224. This datacan then be made the subject of the output along the line 219 and 221 asrequired.

Similarly other databases 208, 209, respectively, have read-outs 225 and226 which can be directly coupled along lines 227 and 228 to the output,or can be directed optionally along lines 229 and 230 to theinterpretation module 218. It can then be the subject of interpretationfor an expert interface 220 review which is, in turn, made the subjectof the output 219 and 221.

In each of the output lines 219, 221, 222, 223, 227, 228, and 214 thereis also provided an encryption program 231 which can be optionally usedin the system. The output 212 can include paper, electronic, or voiceread-out as is required.

In this manner, the output 212 provides a compilation which combines thephysical health and genetic information relating to a subject, thebreed, disease, disorder and lifespan, thereby enabling the receiver ofthe output 212 to use the compiled information in a manner to facilitatebreeding criteria which can be important in relation to animals whichare usually inbred or line bred. The information can also be used tofacilitate on-going monitoring of particular subject animals. The datafrom this system can be used to manipulate and regulate breeding,health, and longevity effectively among animals.

The system of the invention is further described with regard to FIG. 7,which is a system for inputting data to the CDPR 202. Here multipleusers 203, which can be a remote user such as a laboratory, a breeder,an owner, hospital, agent, or an operator of the CDPR 202 accesses thesystem through module 204 which, in turn, accesses the CDPR 202.Appropriate access request and access enable messages are sent. Withinthe CDPR 202 there is a physical health or phenotype module 200, agenetic or genotype data module 201, and other database modules 207,etc. After accessing the CDPR 202, additional data can be added to themodules 200, 201, 207, etc. through any of the users 203, if authorized.Depositing data into each of the modules 200, 201 and 207 can optionallyrequire the payment to the operator of the CDPR 202 as is indicated byblock 205. This system can function in the same manner as the retrievalof data from CDPR 202.

The stored data in each of the blocks 200, 201, and 207 can be set up asindicated by block 232 in a manner which is restricted or unrestrictedto selected users 203. This may be necessary according to the protocolsgoverning the inputted data to the different databases. In some cases,the waiving of deposit fees is made in the interest of freedom of thedatabase to subsequent users who wish to retrieve data from thedatabase. After storage of the data as indicated by block 234, the user203 exits CDPR 202 as indicated by block 233.

As is apparent, the physical health or phenotype profile of subjectanimals is dynamic and grows as more data is added into the system.Likewise, the genetic or genotype database also grows as increasingresearch of particular subjects, breeds, and the like is obtained. Thedeposit of new information into the CDPR 202 is regulated in a mannerthat the data cannot distort the databases 202 in an in appropriatemanner. Likewise, users 203 cannot access the secured databases withinCDPR 202 in an inappropriate manner.

Different algorithms regulate the relationship between the healthprofile, the genetic data, and other data relating to animals. Thesealgorithms determine the probabilities, possibilities, and likelihood ofdisorders and disease in subject animals and offspring animals. They areused as predictors of the future evolvement of health of the animal.

In one example the genetic influence on behavior and behavioraldisorders accounts for less than half of the phenotypic expression ofbehavior and behavioral differences. However, behavior is the mostcomplex phenotype, because it reflects not only the functioning of thewhole being but also is dynamic and changes in response to environmentalinfluences. These results are most dramatically seen in purebred animalsbecause they have been inbred and line-bred to select for a particularbehavior and conformation, even though the genotype of purebred breedsshows almost no variation over 100 years. Examples of this are all thedifferent purebred dog breeds which currently exist, and have widelydisparate size, weight, temperament and lifespans.

Accordingly, if the results of a mostly phenotypic database indicateabnormal thyroid function, then by relating this to the mostly genotypicand combined database categories of breed, age and sex, it is possibleto determine whether the subject has or does not have heritable thyroiddisease, or is likely to develop this condition within a predictedperiod of time.

Similarly, if the phenotypic database indicates elevated blood and urineglucose levels, then by relating this to the genotypic and combineddatabase categories of weight, age, sex, breed and reproductive history,it is possible to determine that the subject has diabetes that is likelyto be of an heritable basis.

Another example relates the phenotypic database indicating low blood vonWillebrand factor level to the genotypic and combined databasecategories of breed, age, sex, and clinical and family history, wherebyit is possible to determine whether the subject has the inherited oracquired form of von Willebrand disease.

Analyzing the data from the CDPR 102 in the manner of the presentinvention permits for genetic screening, health assessment profiling,and the diagnostic, prophylactic, and therapeutic management of animals.

F. Inter-Relationship of the Phenotype and Genotype Database

The determination of the interrelationships between individuals orgroups of individuals in the database can use any one of a number ofcomputerized or other methods of analysis, simple or complex, includingsuch things as neural networking or other kinds of relational technologyevaluative databases.

An exemplary server performs all the operations of a conventionaldatabase system and performs additional operations in accordance withthe present invention as has been discussed, in the previous section,which is incorporated herein. The server includes a central processingunit (CPU) together with associated memory for processing informationabout different animals species and history. The inquiries concernanimals species and history and inquiries and requests for healthprofiling and genetic information, and providing health profiles andgenetic information. The CPU is coupled to the database and to users viaa communications port. The CPU is also coupled to an electronic mailprocessor for processing and storing (in a storage device) e mailmessages transmitted between the CPU and various agents, users and thelike. The CPU is further coupled to a data storage device. A datastorage device may include a variety of the databases. The systempermits for the requesting, storing and providing of data with respectto animal phenotypic information and genetic information. The format andcontent of the databases have been discussed in detail above and isincorporated herein.

FIG. 8 presents an overview of the laboratory instruments apparatus,system, and method operable with the present invention in relation to aCDPR 202. The present invention allows access by remote users withcomputers or processors 100 to receive and access data on specimens.Using the Internet 6 or other computer network or communication linkcapability, the remote user 8 sends a message to request access to theservices provided by the laboratory or operator which has a CDPR 202. Ifaccess to the CDPR 202 is granted, a message is sent to the remote usercomputers 100. This message includes instructions enabling the remoteuser 8 to define and access data stored in the CDPR 202.

In one form of the invention, the desired data is based on thesubmission of test specimens of a specific animal to the laboratory. Insome other cases health profile test data 200 can be inputted into theCDPR 202 having the genetic database 201. The CDPR 202 can perform ananalysis and correlation between the health profile database 200 and thegenetic database 201.

Using the communications link, the remote user 8 communicates with thelaboratory or the CDPR 202. Specimens can be packaged and physicallytransported to the laboratory site via commercially available commoncarriers, such as the postal service or courier services. When thepackages arrive, the laboratory places them in storage, or the tests areperformed. Instruments 300 perform the tests to obtain data as specifiedby the remote user 8. The biohazardous samples can be disposed of awaste material. The test results, or output is provided as part of ahealth profile database 200 of the CDPR 202 and is available to theremote user 8.

If desired, the remote user 8 can arrange to have the data stored in theCDPR 202, made available to other remote users 8. The remote user 8 canalso request the laboratory to perform analysis on the health profiledata 200 generated.

In one embodiment, the communications link is a computer network and themessage transfer modality is, for instance, the Internet 6, and/or anIntranet and/or an Extranet. The network systems are particularly suitedto the application described herein since it offers global or widespreadaccessibility and high speed data transfer of large amounts ofinformation.

A security unit allows remote users to designate who has permission toview or use their data. Feasible options for these informationmanagement requirements include: access by the submitting remote usersonly, access by certain designated researchers and collaborators,time-embargoed data followed by wider access, and unrestricted access byall. A commerce unit can implement functions related to the businessaspects of the CDPR facility, including billing, inventory management ofsupport materials.

A multimedia unit comprises means to store, manipulate, and presentaudio, graphical, video information. This information may include avideo explaining how the CDPR is used, a visual depiction of the data,methodology, or a comment regarding the background of the data. Themultimedia unit may also implement subscription functions, so thatupdated data automatically provided to remote users or other interestedparties.

The operations performed by the present invention begins when thecontroller receives an access request message from the remote user via acommunication link. Using information in the access request message andany other available information, the controller determines if the remoteuser is authorized to access the CDPR 202. If so, an access enablingmessage is transmitted from the controller to the remote user 8. Theaccess enabling message can comprise a set of computer instructionstransmitted over the Internet 6 which is downloaded into the remote usermemory for execution by the remote user processor. These instructionsmay be enabling, that is, they may allow direct communication betweenthe remote user 8 and the CDPR 202 with no further need for thecontroller. In another embodiment, the access enabling message maysimply comprise a password or other enabling message which allows theremote user 8 to proceed. The remote user 8 can access or submit data tothe CDPR 202 according to different protocols and regimes and securityarrangements.

Different forms of expert system computing and software programming canbe used to determine the relationship of the data bases and data.Parallel distributed processing, and neuromorphic systems, such asneural networks can be used. They are good pattern recognition enginesand robust classifiers, with the ability to generalize in makingdecisions about imprecise input data. There are multitudes of differenttypes of networks such as a multilayer perception which is generallytrained with the backpropagation of error algorithm, learning vectorquantization, radial basis function, Hopfield, and Kohonen. Some arefeedforward while others are recurrent (i.e., implement feedback)depending on how data is processed through the network. Some may requiretraining while others are unsupervised or self-organizing. This can beimplemented in software or in specialized hardware.

Alternatively or additionally fuzzy logic can be used due to the dynamicnature of the data applications, rules and functions. Such logic isadaptive to the changing environment. This logic and the neural networkscan be integrated in the system.

Adaptive Logic Networks technology is an effective alternative oradditional technology. The Adaptive Logic Network is neurocomputingcapable of modeling complex non-linear systems by using piece-wiselinear data The inputs to an Adaptive Logic Network may be the data fromlarge databases as described, observations recorded by a scientist,veterinarian or owner. The outputs of an Adaptive Logic Network can beused for analysis, prediction, or real-time management.

G. EXAMPLES

The following examples are included to demonstrate preferred embodimentsof the invention. It should be appreciated by those of skill in the artthat the techniques disclosed in the examples which follow representtechniques discovered by the inventor to function well in the practiceof the invention, and thus can be considered to constitute preferredmodes for its practice. However, those of skill in the art should, inlight of the present disclosure, appreciate that many changes can bemade in the specific embodiments which are disclosed and still obtain alike or similar result without departing from the spirit and scope ofthe invention.

Example 1 Temperament and Longevity

Test panels Nos. 1, 2, 3, 8 and 10 set out in the above section can beused to obtain data for this Example.

Briefly, characteristics related to the temperament of the animal, whichimpacts on its longevity, are determined. Biological laboratory testdata from a bodily fluid or tissue of an animal are analyzed. Such testdata relate to the level of neurotransmitter activity of the animal. Thedata relate to at least one of the value of serotonin,gamma-aminobutyric acid (GABA), glutamate, dopamine, glycine, aspartate,acetylcholine, norepinephrine, histamine, substance P, vasopressin,vasoactive intestinal peptide, neurotensin, or the other neuropeptidesof the animal. The value should fall within predetermined levels as apredictive determinant of the animal's temperament (passivity,assertiveness, or aggressivity).

Methods for measuring neurotransmitters are well known in the art.Neurotransmitters such as serotonin, epinephrine, norepinephrine,glutamate, and GABA can be measured by standard immunochemicaltechniques involving commercially available antibodies, eitherpolyclonal or monoclonal. Such antibodies are commercially availablefrom sources such as Sigma Chemical Company (St. Louis, Mo.). Theseimmunochemical techniques can involve either radioimmunoassay or otherwell-established assay techniques, such as ELISA (enzyme-linkedimmunosorbent assay). These neurotransmitters can also be measured bystandard non-immunochemical techniques such as gas chromatography.Neuropeptide neurotransmitters are preferably measured by immunochemicaltechniques.

Example 2 Immune Stimulation and Cellular Inflammatory Response

Test panels Nos. 1, 3, 4, 8, 9 and 10 set out above can be used toobtain data for this Example.

Characteristics related to at least one of the immune stimulationreaction, evidence of neoplastic or paraneoplastic change, or thecellular inflammatory response of the animal are determined. Biologicallaboratory test data from a bodily fluid or tissue of an animal areanalyzed. The test data relates to at least one of cell cytotoxicitymarkers, cytokine and chemokine levels, immunoglobulin levels, type andamount of lymphocyte subsets and lymphocyte markers, and markers ofneoplastic or paraneoplastic change of the animal. The value should fallwithin predetermined levels as a determinant of the immune stimulationreaction, neoplastic or paraneoplastic change, or the cellularinflammatory response.

Methods for measuring lymphokines and other cytokines are well known inthe art. These compounds are typically measured by immunochemicaltechniques using commercially available monoclonal antibodies or othermethods.

Example 3 Inherited Organ Dysfunction or Dysplasia

Test panels Nos. 1, 3, 5, 9 and set out in the above section can be usedto obtain data for this Example.

Characteristics related to inherited organ dysfunction or dysplasia ofthe animal, at least one of which is neuronal, neuromuscular or renalare determined. Biological laboratory test data from a bodily fluid ortissue of an animal are analyzed. The test data relate to an amino acid,carbohydrate, lipid or other metabolic component, body fluid or tissuemarker of the animal. The data includes obtaining data related to atleast one of the value of the methyl malonic acid, the fucose-containingcell metabolites, blood or urine urate or uric acid metabolites,normoglycemic glycosuria, mannosidase containing cell metabolites, aminoacid uria, amyloid deposition in tissues, neuronal ceroid lipofuscindeposition, and deposition of gangliosides and other lysomal storagesubstrates of the animal. The value should fall within predeterminedlevels as a determinant of the inherited organ dysfunction or dysplasia.

Example 4 Autoimmune Thyroiditis

Test panels Nos. 1, 2, 3 and 10 set out in the above section can be usedto obtain data for this Example.

Characteristics related to autoimmune thyroiditis of the animal aredetermined. Biological laboratory test data from a bodily fluid ortissue of an animal are analyzed. The test data relate to a geneticmarker for automimmune thyroiditis of the animal. The data relates to atleast one of the results of a comprehensive thyroid antibody testprofile, DNA fingerprint (the gene map), and markers for immunoglobulinreceptors on B-cells, T-cell receptors, and protein products of themajor histocompatibility complex (MHC) genes (Class I and II allellicHLA, DLA or equivalent antigenic specificities of the animal. Testassays to screen for MHC genes include restriction fragment lengthpolymorphism (RFLP), polymerase chain reaction (PCR) RFLP, PCRsequence-specific oligonucleotides (SSO) and PCR sequence-specificprimers (SSP). The value(s) should fall within predetermined levels as adeterminant of autoimmune thyroiditis.

Example 5 Mammary Cancer

Test panels Nos. 1, 2, 3 and 10 set out in the above section can be usedto obtain data for this Example.

Characteristics related to presence of or susceptibility to mammarycancer of the animal are determined. Biological laboratory test datafrom a bodily fluid or tissue of an animal are analyzed. The test datarelate to estrogen (estradiol-17β), estrogen receptors, interleukin (IL)6, progesterone, and progesterone receptors. The value should fallwithin predetermined levels as a determinant of the presence of orsusceptibility to mammary cancer.

Example 6 Immune Surveillance

Test panels Nos. 1, 3, 5, 6, 8, 9 and 10 set out in the above sectioncan be used to obtain data for this Example 6.

Characteristics related to the tissue environment of the eye and brain(ocular and blood-brain barrier) which are sites protected from thenormal immunologic surveillance mechanisms are determined. Biologicallaboratory test data from a bodily fluid or tissue of an animal areanalyzed. The test data relate to the soluble and cellular immuneinflammatory response mediators (cytokine and chemokine levels,immunoglobulin levels, and lymphocyte susbset markers). The value shouldfall within predetermined levels as a determinant of integrity ofprotected immune surveillance mechanisms.

Example 7 Inherited Bleeding Disorders

Test panels Nos. 1, 7, and 9 set out in the above section can be used toobtain data for this Example 7.

Characteristics related to the tendency to bleed excessively aredetermined. Biological laboratory test data from a bodily fluid ortissue of an animal are analyzed. The test data relate to acomprehensive assessment of the hemostatic and coagulation function. Thevalue should fall within predetermined levels as a determinant of thepresence of bleeding disorder.

Example 8 Comprehensive and Cumulative Database for Animal Health

An initial database, from a recent temporal period made on a group ofhealthy dogs, may use physical characteristics, health history, andcomprehensive laboratory data of these dogs for a specific geographicarea such as the U.S.A. and Canada, but also other geographic areascould be used. Additional databases are developed for other countries.Generally the same laboratory is used to generate the database. Thetemporal retrospective database are augmented in an on-going fashionwith prospective data that continues to accumulate over the futuretesting years. Results are analyzed from the temporal retrospectivedatabase and then are periodically reanalyzed every 6-12 monthsdepending on the size of the database to search for any trends or driftin the values of specific analytes over time.

This is an important database to accumulate because the presence ofdrift over time means that subsequent studies of the same or otheranimals, whether they be healthy or have diseases, disorders or changesin lifestyle, diet or other parameters including reproduction, orperformance use need to take such drift in the database into account inorder to accurately interpret the values obtained. Animals of specificbreed or type characteristics, size, age, weight, performance level,lifestyle, geographic location have their laboratory profiles andphysical characteristics and health history entered into a database thatstarts from entry into the system and continues on a regular basis overtime, preferably at least annually. Also entered into this database arepuppies that are tested for the first time at about six months of age,pre-puberty, and then before puberty, preferably in anestrus females,and then annually thereafter in a comprehensive manner to establish acumulative laboratory database for the individual animal.

These data are put into a group-specific database for the breedcharacteristics or the activity characteristics or any other parameterthat is useful to group together for analytical purposes. This method ofgathering comprehensive and cumulative data permits not only analysis ofindividual animals, whether they be healthy or expressing some stage ofdisease or disorder, but also allow analysis of their membership in agroup. When the group is analyzed it provides a database for predictivelaboratory value expectation for similar members of the group. Bydeveloping these databases in a cumulative manner the trends forparticular analytes or groups of analytes predictive of organ function,for example, can then be compared within individual animals, healthy ordiseased, with that of the retrospective and prospective healthy animaldatabase to look for differences in trends. Those differences in trends,as well as differences in individuals or groups of animals, can then beused as a predictor of health, disease and longevity.

Once trends or changes are identified within individual animals, orwithin the related groups of animals, or within specific analytes orgroups of analytes from a database, this permits intervention in amanagement and treatment perspective. The intervention can benutritional, can include the use of dietary supplements, use of specificnutraceuticals, and can include, of course, other conventional andalternative treatments and management of health care.

The database so gathered, while primarily phenotypic in its laboratoryanalytical sense and its patient descriptive sense, is also predictivefor the most part of the genotype of the individual animals or groups ofanimals in the population, because the canine genome has changed verylittle over the last hundred years, and so the majority of the caninegenome is identical between dog breeds and individual dogs. Differencesin phenotype (physical appearance and size and weight, for example)within dog breeds constitutes a very small genetic variation, less than1%, within the overall genome. Predicting genotype and phenotype withthese comprehensive and cumulative laboratory test panels permits anovel approach to intervening in the management and treatment of caninedisease and disorders and also in the maintenance of canine health andlongevity.

The comprehensive cumulative database developed allows one to look atvery early subtle changes that are consistent within individuals orgroups of related individual dogs, or animals within a related group sothat one can predict disease sooner, make interventions that are lessexpensive, less invasive, and more effective, and thereby reverse theprocess before it becomes more serious clinically.

One of the most effective and least invasive or harmful ways tointervene in promoting animal health and longevity is to utilize dietarymanagement. Specifically, wholesome foods are the key to a balancedfunctioning immune system and the resistance to disease. Given the tightdatabase that is developed by this approach, extraneous noise in theresults of comprehensive laboratory analyses is minimized. One can takethe findings then for individual animals or groups of animals havingcumulative laboratory evidence of trends or drift from the normal rangesand design specific dietary interventions that rebalance the system andpromote immunological function and resistance to disease.

This method of identifying what changes can be made in dietarycomponents or supplements does not depend on a single point in time ofan individual pet or other animal data, but in fact the key isdeveloping a cumulative comprehensive database over time for normalanimals in a like-group location or activity level, as well as specificanimals within the group in order to determine what trends are evidencedover time and thereby use the trend to give a more solid determinationof what changes are to be made in nutritional requirements ornutritional supplements or other interventions.

Example 9 Thyroid Function

A specific example is the diagnostic test panel for thyroid functionwhich depends upon the comprehensive diagnostic test panel and then morespecific tests focused on the thyroid, including molecular-based testingand genomic mapping.

Thyroid disease is the most common endocrine dysfunction in companionanimals. Thyroid hormone plays a role in metabolism, growth andmaturation of the skeletal system, growth and maturation of the centralnervous system, and temperature regulation. Early detection of thyroidimbalance allows one to intervene, specifically with nutritionalsupport, and managing individual foodstuffs and supplements thatoptimizes thyroid function before the disease progresses to the stagewhere thyroid hormone supplement becomes an essential component of themanagement and treatment. For instance, food supplements containingkelp, iodine and the minerals from green leafy vegetables are helpful inenhancing thyroid function. Soybean-derived foods and certain othervegetables, by contrast, tend to inhibit thyroid function, as can theprotein quality and content in the diet.

In addition to the physiological roles that thyroid hormone plays, it isalso recognized that thyroid function plays a role in behavior. Socialinteraction of the animal with its caregivers is the key to having anindividual animal become a successful companion animal member of ahousehold. If the animal has an undesirable behavior or social badhabits, very likely the animal is isolated, stressed, and may be treatedunkindly and even ostracized by some family members, so that the animalmay eventually be given up or even sent to a pound or shelter and bekilled. If kept by the family, the animal may undergo significant stresswhich contributes to immune suppression and lack of well-being and thusfurther promotes the abnormal behavior. Thus, it is important to detectthyroid imbalances early in the animal's life.

Thus, the comprehensive individual and group databases of the presentinvention are used to assess overall health, and specifically thyroidfunction. By using this database and identifying animals that have veryearly subtle changes in laboratory analytes shown by their individual orcumulative data drift from the expected normal parameters, one canintervene before the abnormal behavior becomes unbearable for the familycaregivers. Yet further, one can intervene before the thyroid imbalanceleads to other health concerns, such as poor metabolism.

As it is well known that specific breeds that are used for performanceevents can have quite different basal thyroid metabolism, for examplesighthounds and other coursing breeds vs. toy breeds or working breeds,it is important in the cumulative database to determine thesecharacteristics by comprehensive profiling of this group as a whole, sothat the data for individual animals could be compared to the group.Values for this specific functional group by breed are then compared tothe entire database for the canine as a species and specific trends overtime are developed relating to age and to environmental influences. Oncethe specific determinants of the individuals and the group that theybelong to have been made, the trends that have been identified are usedto modify and intervene to promote health and longevity, specificallyagain with modifications to dietary components or supplements as well asother changes in lifestyle, including exercise, group housing,individual housing and parameters that would promote wellness andlongevity.

Example 10 Management of Health Using Nutrition

There is a need in the animal health industry for more tightlycontrolled and designed nutritional supplements and nutraceuticals(i.e., treats) for companion animals such as dogs and cats in order tobalance their overall nutritional requirements and thereby improve theirimmunologic function, health, resistance to disease, and longevity. Thisneeds to be accomplished by taking into account the specific descriptorsof the animal such as the breed, age, sex, weight, lifestyle, geographiclocation, and particular breed function or performance type. These breedand specific animal descriptors need to be linked to some kind oflaboratory and general animal health and medical history information.

These nutritional supplements, foodstuffs and/or treats may have a widevariation in terms of flavor, size, and/or shape. For example, a packetin flake form that is sprinkled on top of food; a granola bar; abiscuit; freeze-dried food; or a chewable training treat. Yet further,the nutritional supplement and/or treat may be in a variety of formatsthat are user-friendly and encourage the owner to purchase it for thebenefit of the pet and the pet to eat it.

This example is directed at combining the health information and medicalhistory, including laboratory data which can be simple or comprehensiveand cumulative, in order to select a specific nutritional supplement,nutraceutical, treat and/or foodstuff that can correct any imbalancesnoted in the medical and laboratory health information. This database tohelp with nutritional management also includes genetic informationwhenever it is available and combines all of this into a general profileof the specific characteristics of that animal or the animal group thatit belongs to. This profile may include retrospective information,current information, and prospective information. At least one of or allof these may be used to determine what the appropriate nutritionalmanagement measurements should be.

Implementation of this example is effected by defining which formula ofnutritional supplement may be added to the basic food that isappropriate for the animal. Alternatively, the implementation is morecomplex, where highly, tightly evolved, comprehensive, cumulativedatabase for that particular animal is used to determine which treat isavailable.

In one implementation of this system, for example, the pet owner goes toa grocery store or a large pet food supply distributing store andselects the appropriate nutritional supplements, nutraceuticals, treatformulations, or foodstuffs for that animal. The store provides thearray of supplements and foodstuffs to select from. It has acomputer-generated memory database for that specific pet. Theinformation is given a code based on the owner's name, etc., and otherinformation. The owner has a specific number for that, punches their ownspecial confidential number into the computer. The computer thenindicates which of the appropriate nutritional supplements,nutraceuticals, treat formulations, or foodstuffs can be selected. Thepurchaser then goes to the store shelf and picks the one that isappropriate for them. Thus, the owner can take the basic basal food thatthe animal needs and adds to that the appropriate supplement customizedand unique for that individual.

Specific basal diets already exists in the animal/pet food industry—forexample, foods for puppies, for adults, for geriatrics, for animals withspecific disease states like kidney disease or liver disease or obesityor skin problems or a variety of options. This example builds on this.

As an example, the information in the computerized stored database inthe specific store or by identification card is put into the machinewhich the owner keeps. The card contains all the medical history andalso indicates which treat, by number or color code or specificdescription matches and can be added to the appropriate basal food.Thus, the food purchased is an added nutritional supplement or treat toadd to the basic food that has also been determined to be appropriatefor that pet.

This is a simple, easily-adapted, commercially viable program tooptimize the health and well-being and longevity of companion animals.Specifically, this program is developed as a matching system whereby theinformation provided selects the appropriate basal diet and then matchesthat with the specific supplement that is needed for the individualanimal or family or group.

The computer terminal user database at the point of sale can beconnected to an offsite computer storage database where moresophisticated information is available and stored and would process itthere in order to give the remote user, within a few minutes, theappropriate formula that is necessary. This operates in a manner similarto an automated teller machine system at a bank, where there is acentral computer that stores all of the database specific and unique tothat individual with a pass code that is necessary.

The technology of the example can be applied to veterinary clinics andlarger veterinary hospitals, where the veterinarian can be theprofessional individual inputting the information to select theappropriate nutraceutical or treat for the pet. In this case, one canenvision that the veterinarian may be using more therapeutic prescribedsupplements to balance the health of the animal, as opposed to moregeneral supplements that might be available, for example at a grocerystore or a specialty pet supply outlet.

This example can be extended further, where the owner or the veterinaryclinic or other health professional can actually connect through theInternet with a wholesaler or a manufacturer of the food or specificnutritional supplement desired and order it that way for directdelivery.

Other information at point of sale that can be provided may include suchcustomized packaging or labeling of the product can include photographs,specific descriptors, as well as name of the individual animal, that maycome out as a preprinted label that could be put on the specific chosensupplement or treat, and also health care advice and other printedmaterial specific for the maintenance and well-being of that pet,including such things as preventive dentistry, annual wellness exams.All of that can be tied together so that when the person accesses thisinformational base to obtain the specific nutritional supplementrequired, that all kinds of additional information on a positive senseto provide the owner with a user-friendly synopsis of health would alsobe available. In addition to this information being available inhardcopy form at the point of sale, it can also be made electronicallyavailable through the Internet or some other access code system orcommunications system.

This system uses pre-selected and pre-prepared formulas to match withthe specific needs of the individual companion animal, family, or animalgroup. The advantage of this system is that these pre-prepared variousnutritional supplement products may be made under the tightest controlat a manufacturing plant, rather than just being mixed together at thepoint-of-sale site, where errors could occur and quality control wouldnot be monitored properly.

Many other examples of the invention exist, each differing from othersin matters of detail only. The invention is to be determined solely bythe following claims.

Example 11 Modulation of Disease

It is also envisioned that genotypic data can be used to identifyanimals that are susceptible to a disease. Once the genetic predictorsof disease susceptibility are determined, then a nutritional regimen isestablished to modulate the disease. It is contemplated that themodulation of the disease results is inhibition and/or prevention of thedisease.

The nutritional regimen uses pre-selected and pre-prepared formulas offood to match the specific needs of the individual companion animal,family, or animal group. Nutritional supplements and/or treats may alsobe used either in combination with the pre-selected and pre-preparedfood formula or alone. Nutritional supplements that are used may includevitamins, anti-oxidants, nutraceuticals, etc. It is envisioned that thenutritional supplement and/or treat may be in a variety of formats thatare user-friendly and would of course encourage the owner to purchase itfor the benefit of the pet and the pet to eat it.

The method of determining a nutritional regimen may be implemented usingany of the databases and systems described herein and incorporated intothis Example by reference. For example, the pet owner goes to a grocerystore or a large pet food supply distributing store and selects theappropriate nutritional supplement for that animal. The store providesthe array of supplements to select from. It has a computer-generatedmemory database for that specific pet. The information can be given acode based on the owner's name, etc., and other information. The ownercan have a specific number for that, punches their own specialconfidential number into the computer. The computer then indicates whichof the appropriate nutritional supplements, nutraceuticals, treatformulations can be selected. The purchaser then goes to the store shelfand picks the one that is appropriate for them. Thus, the owner can takethe basic basal food that the animal needs and adds to that theappropriate supplement customized and unique for that individual.

Yet further, it is envisioned that a database is not required todetermine a nutritional regimen. For example, a single DNA test isemployed that determines a specific DNA marker and/or markers that arepredictors of disease susceptibility. Once a DNA marker has beenidentified, a nutritional regimen is determined that intervenes andmodulates the development of the disease. Thus, it is envisioned that aDNA test can determine disease susceptibility and the disease can beprevented and/or inhibited by implementing a nutritional regimen.

Although the present invention and its advantages have been described indetail, it should be understood that various changes, substitutions andalterations can be made herein without departing from the spirit andscope of the invention as defined by the appended sentences. Moreover,the scope of the present application is not intended to be limited tothe particular embodiments of the process, machine, manufacture,composition of matter, means, methods and steps described in thespecification. As one of ordinary skill in the art will readilyappreciate from the disclosure of the present invention, processes,machines, manufacture, compositions of matter, means, methods, or steps,presently existing or later to be developed that perform substantiallythe same function or achieve substantially the same result as thecorresponding embodiments described herein can be utilized according tothe present invention. Accordingly, the appended sentences are intendedto include within their scope such processes, machines, manufacture,compositions of matter, means, methods, or steps.

REFERENCES

All patents and publications mentioned in the specifications areindicative of the levels of those skilled in the art to which theinvention pertains. All patents and publications are herein incorporatedby reference to the same extent as if each individual publication wasspecifically and individually indicated to be incorporated by reference.

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1. A method of managing the health care and well-being of anon-livestock animal comprising the steps of: a) obtaining a databaserelating to at least one of: i. species of the animal, ii. a selectedgroup of the species; b) obtaining data relating to the animal, the dataincluding laboratory test data relating to the animal; c) relating thedatabase of a) with the data of b) by a computer; and d) determining,based on c), a regimen for the management of the animal.
 2. A method ofmanaging the nutrition of a non-livestock animal comprising the stepsof: a) obtaining a database relating to at least one of: i. species ofthe animal, ii. a selected group of the species; b) obtaining datarelating to the animal, the data including laboratory test data relatingto the animal; c) relating the database of a) with the data of b) by acomputer; and d) determining, based on c), a nutritional regimen for themanagement of the animal.
 3. A method of managing the health of anon-livestock animal comprising the steps of: a) obtaining a databaserelating to at least one of: i. species of the animal, ii. a selectedgroup of the species; b) obtaining data relating to the animal, the dataincluding diagnostic laboratory test data relating to the animal; c)relating the database of a) with the data of b) by a computer; and d)determining, based on c), a therapeutic intervention or maintenance forthe management of the animal.
 4. The method of claim 1, wherein furthercomprising obtaining genetic profile data relating the animal.
 5. Themethod of claim 1, wherein the species and animal are canine.
 6. Themethod of claim 1, wherein the species and animal are feline.
 7. Themethod of claim 1, wherein the database of the selected group of thespecies is at least on of breed, age, sex, size, weight, performanceuse, or geographical location.
 8. The method of claim 2, wherein thenutritional regimen is selected from the group consisting of foodstuffs,treats, drinks, nutritional supplements, holistic treatments andexercise.
 9. The method of claim 3, wherein the therapeutic interventionor maintenance is selected from the group consisting of drugs,nutraceuticals, nutritional supplements, holistic treatments andexercise.
 10. The method of claim 1 wherein the diagnostic laboratorytest data is a comprehensive general health profile and selectively atleast one selected diagnostic profile for a selected subject.
 11. Themethod of claim 1 wherein the computer uses at least one of an expertsystem or interrelationship program or network for determining databaseand data relationships.
 12. The method of claim 1 including the step ofreporting the determination on a communications network including theInternet.
 13. The method of claim 1 including the step of reporting thedetermination on a communications network including the Internet, andobtaining payment for the report through the Internet.
 14. A method ofmodulating disease in a non-livestock animal comprising the steps of: a)obtaining a database relating to at least one of: i. a species of theanimal ii. a selected group of the species; b) obtaining genotypic datarelating to the animal, the genotypic data includes genetic profile datarelating to DNA markers associated with the disease. c) relating thedatabase of a) with the data of b) by a computer; and d) determining,based on c), a nutritional regimen to modulate the disease.
 15. Themethod of claim 14, wherein modulating is inhibition of the disease. 16.The method of claim 14, wherein modulating is prevention of the disease.17. A method of modulating a disease in a non-livestock animalcomprising the steps of: a) performing a DNA test to determine a knownDNA marker associated with a disease; b) obtaining the data from the DNAtest; and c) determining based on b), a nutritional regimen to modulatethe disease.